Events

Retiro De Equipo (Recall) de Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00617-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00617-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    This is a follow up action to rc-2013-rn-00124-1. medtronic issued an urgent recall for product correction to inform surgeons of the potential for the proximal end of the dbs lead to be damaged when the connector block of the dbs lead cap twists within the assembly when turning the set screw during step 1 of dbs surgery. the damage would most likely occur at lead contact number 3 which could affect electrode contact number 3. there is a 5.0 in-oz requirement on the lead cap assembly specification. recent testing indicates that this requirement is not being met.Medtronic has implemented manufacturing process changes that address the twisting of the setscrew connector block within the lead cap and is now removing any unused product that was distributed to customers prior to implementing the change.
  • Acción
    Medtronic is advising their customers that a sales representative will organise for the return of all affected stock. Surgeons are also advised that the work around instructions described in recall RC-2013-RN-00124-1 are no longer necessary for new lots of the product.

Device

Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator)
  • Modelo / Serial
    Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator)Model Number: 3387ARTG Number: 137374Model Number: 3389ARTG Number: 137138Model Number: 3391ARTG Number: 174469
  • Clasificación del producto
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA